Table 1.
Applied inclusion and exclusion criteria.
Inclusion Criteria (Included Studies Must Satisfy All the Following to Be Included) |
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The vaccine under surveillance must be approved by the World Health Organisation (Novavax (NVX-CoV2373), COVOVAX (Novavax formulation), Moderna (mRNA-1273), Pfizer/BioNTech (BNT162b2), Janssen (Ad26.COV2.S), Oxford/AstraZeneca (AZD1222), Covishield, Covaxin, Sinopharm (BBIBP-CorV -Vero Cells), Sinovac (CoronaVac)15 |
The surveillance method described must include a digital solution/technology, such as an app, e-mail, SMS, website, and/or e-questionnaire (a mix of digital and non-digital was allowed as long as results were separated out, with digital outcomes specifically reported on, such as response rate) |
The study describes post-market AEFI surveillance (Phase IV studies, post-market reports, etc.) |
The manuscript is primary research |
The AEFI surveillance type is “active,” defined as being directly instructed/prompted to respond (solicited AEFI reports) and is patients/participants/vaccinees centered |
English language full text, manuscripts are available (matching language proficiencies of investigators) |
Study must report the following:
|
Exclusion Criteria (Record Excluded if Any of the Following) |
The vaccine under surveillance is not approved by the World Health Organization (mix was allowed if results were separated out with specific outcomes reported for approved vaccines) |
The publication is not primary research (narrative review, editorial, letter, comment, opinion piece) |
The study does not describe post-market AEFI surveillance |
Abstract and/or poster only available which do not provide sufficient detail for interpretation and data extraction |
Surveillance reports came from manufacturers, healthcare providers, and/or non-vaccinee/patient/participant sources |
Passive surveillance or administrative data studies (mix was allowed if results were separated out with specific outcomes for active surveillance components) |
Non-digital solution/technology used for AEFI surveillance, including phone interviews, assisted calling, diary cards, paper forms, etc. (Mix was allowed if results were separated out with specific outcomes for digital AEFI surveillance components) |
Full text, in English to meet investigator language proficiency, is not available and/or accessible |
The method of surveillance and the components of digital surveillance were unclear, and interpretation of the approach taken was not possible due to an absence of description and details regarding the methods applied. |